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Nonsubstantive Review in Certificate of Need

If you are familiar with the healthcare industry, you should know about Certificates of Need (CON). In Kentucky, healthcare providers are required to obtain a CON before building, expanding, or initiating certain facilities or services. Essentially, a CON is a regulatory tool that requires healthcare providers to seek approval from the state. Because the CON process is designed to curb rising healthcare costs and prevent superfluous duplication of services, applicants must demonstrate an evidence-based need for a service or facility in a particular area.

CON formal review criteria can be a lengthy process, taking generally anywhere from three to twelve months. Nonsubstantive review, however, tends to be an abbreviated process for projects granted such evaluation. This process is frequently implemented for specific projects, including adult day care centers, equipment replacements, cost escalations, relocating or replacing a licensed facility with no changes in bed capacity, establishing industrial ambulance services, or projects with no established criteria in the State Health Plan.

Under nonsubstantive review, there’s a presumption that the facility or service is needed. This presumption of “need” is rebuttable under the CON regulations. In formal review of CON applications, the criteria must be acceptable from proof in the application. A party in opposition (the affected party) to the nonsubstantive review application has a right to challenge it. This opposition takes the form of a request for an administrative hearing. These types of hearings are formal in nature. Affected parties may request a hearing, but under the review process, an opposing party must prove a need for a facility or service does not exist by clear and convincing evidence. When an application is not approved, an applicant is left with three options: (1) pursuing a formal review process; (2) requesting reconsideration from the hearing officer; or (3) appealing the decision to the Franklin Circuit Court.

The regulatory maze concerning the nonsubstantive review for a CON application may appear to be daunting, but the rationale is to prevent the proliferation of unnecessary healthcare services.